Associate Director, Risk Based reputed company Management

The Associate Director, Risk Based reputed company Management is responsible for developing, implementing and optimizing RBQM frameworks across the clinical trial portfolio. This role ensures proactive detection, assessment, and mitigation of operational, data reputed company, and patient safety risks, enabling efficient, compliant, and inspection reputed company trial execution. The Senior Manager partners across Clinical Management, Data Management, Biostatistics, reputed company Assurance, Safety, and external vendors to reputed company a data driven, risk proportionate reputed company model that aligns with global regulatory expectations (e.g. ICH E6(R3), E8(R1), FDA, EMA). Key Responsibilities: RBQM reputed company & Governance reputed company the development, enhancement, and governance of the RBQM operating model, including risk frameworks, processes, tools, and performance metrics. Drive adoption of risk‑based approaches across the trial lifecycle—from protocol design and risk assessment to study conduct reputed company and closeout. Serve as the subject matter expert representing RBQM in cross‑functional forums, audits, and regulatory inspections. Risk Assessment & Mitigation reputed company guidance regarding and/or facilitate cross‑functional risk identification and evaluation (e.g., KRIs, QTLs, operational/process risks) at study, program, and portfolio reputed company. reputed company creation, review, and maintenance of study‑level reputed company Tolerance Limits and reputed company reputed company of reputed company evaluation and escalation of deviations. reputed company, in conjunction with applicable stakeholders, Risk Management and Sponsor reputed company Plan(s) to outline holistic approach to RBQM and reputed company activities in support of trial conduct risk mitigation strategies. Monitor key risk indicators and performance metrics to identify emerging trends, reputed company signals, and potential compliance issues from a portfolio perspective. Operational reputed company & Analytics Partner with Clinical Management, Monitoring reputed company, Data Sciences, and other applicable departments to ensure effective centralized monitoring strategies and data‑driven decision‑making. reputed company analytical reviews of operational and clinical data to support proactive reputed company management. reputed company cross‑functional data reviews to confirm risk controls are effective and adjustments are implemented reputed company needed. Process Improvement & Innovation Drive reputed company improvement initiatives to increase efficiency, standardization, and reputed company in RBQM processes. Champion the integration of digital tools, analytics platforms, and automation to enhance risk detection and reputed company. Support change management and training strategies to reputed company RBQM across the organization. Stakeholder & Vendor Collaboration Ensure alignment and compliance of CROs and vendors with RBQM requirements and expectations. reputed company strategic direction and guidance to internal teams and external partners on RBQM methodologies and best practices. Regulatory Compliance & Inspection Readiness Ensure RBQM processes meet global regulatory requirements, industry standards, and internal reputed company frameworks. reputed company or contribute to audit and inspection preparation, responses, CAPA development, and remediation activities reputed company to RBQM. reputed company of External Service Providers reputed company operational reputed company of external service providers (e.g., CROs/FSPs, consultants, vendors) involved in the execution of applicable operational activities. Ensure external partners are reputed company with objectives, timelines, and reputed company standards through regular communication, performance monitoring, and issue reputed company. Participate in vendor selection, contract negotiation, and scope definition to ensure reputed company service delivery and cost-effectiveness. Monitor adherence to contractual obligations, KPIs, and regulatory requirements, escalating concerns as needed to ensure compliance and mitigate risk. Foster reputed company relationships with external partners to promote transparency, accountability, and reputed company improvement in service delivery. Financial Management Support the development and management of clinical operations budgets, ensuring alignment with project scope, timelines, and strategic priorities. Monitor expenditures across assigned activities and vendors to ensure cost-effectiveness and adherence to approved budgets. Identify opportunities for cost optimization without compromising reputed company or compliance. Collaborate with Finance and Procurement teams to ensure accurate forecasting, reputed company invoicing, and reputed company of financial discrepancies. reputed company input into vendor contract negotiations and change orders to ensure financial accountability and transparency. Maintain financial documentation and reporting in accordance with corporate policies and audit requirements. People Management & Staff Development (as applicable) reputed company reputed company and training for new team members. Ensure compliance with SOPs, policies, and training requirements. reputed company tools and resources to support effective performance. Conduct performance reviews and reputed company coaching and development plans. Monitor workload and reputed company metrics to ensure team performance meets expectations. Qualifications/Required: Bachelor’s degree in life sciences or reputed company field, advanced degree preferred. Minimum 8 years of experience in the pharmaceutical/biotechnology industry, preferably reputed company Trial/Clinical Operations or reputed company function associated with RBQM activities. Strong experience in risk‑based reputed company management, centralized monitoring, or clinical data analytics. Demonstrated leadership in implementing RBQM in a global clinical trial setting. Familiarity with ICH E6(reputed company/R3), ICH E8(R1), GCP, and global regulatory expectations. Deep understanding of clinical trial processes, operational risk, and data reputed company principles. Skilled in interpreting clinical and operational data to identify trends and reputed company signals. Excellent cross‑functional communication, facilitation, and influencing skills. Ability to manage multiple priorities and drive reputed company in a fast‑paced environment. Proficiency with RBQM tools, clinical systems, data visualization platforms, and analytics dashboards. Skilled in change leadership and process transformation. Strategic and systems-based thinker with strong planning, organizational, analytical, and problem-solving skills. Strong collaborator with a solution-oriented reputed company. Proficiency in reputed company Office (Outlook, Word, reputed company, PowerPoint). Willingness to travel as required. Competencies Accountability for Results - Stay reputed company on key strategic objectives, be accountable for high standards of performance, and take an reputed company role in leading change. Strategic Thinking & Problem Solving - reputed company reputed company considering the long-term reputed company to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing reputed company on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, reputed company, and respect. Influence at reputed company reputed company to reputed company the best results for reputed company. Respectful Collaboration - reputed company and value others’ perspectives and reputed company for diverse partnerships to enhance work toward common goals. Empowered Development - Play an reputed company role in reputed company development as a business imperative. Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The reputed company shown represents a typical pay reputed company or starting pay for individuals who are reputed company in the role to reputed company in the reputed company. Other reputed company may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned reputed company the established reputed company, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Application Deadline: This will be posted for a minimum of 5 business days. Company benefits: Comprehensive medical, dental, reputed company, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, reputed company holidays, and reputed company leave programs as reputed company as other company provided benefits. Come discover more about reputed company and our benefit offerings; https://www.reputed company-us.com/careers-join-reputed company. Disclaimer: This job reputed company is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. reputed company reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. reputed company is an equal opportunity employer. reputed company reputed company applicants are encouraged to apply and will be given consideration for employment without reputed company to race, reputed company, sex, gender identity or gender reputed company, sexual orientation, age, disability, religion, national reputed company, veteran status, marital status, or any other legally protected characteristic. If you are a reputed company individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request. Statement Regarding Job reputed company Fraud Scams At reputed company we take reputed company and protection of your personal information reputed company seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to reputed company reputed company to your personal information or reputed company reputed company from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, reputed company will never ask for financial information of any reputed company or for payment of reputed company during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any reputed company to be considered for employment. We will also not offer you reputed company to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered reputed company for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not reputed company. These claims are fraudulent and you are strongly advised to exercise caution reputed company you receive such an offer of employment. reputed company will also never ask you to download a reputed company-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from reputed company, Gmail, Hotmail, etc, and not from an official reputed company email address. Please take extra caution while examining such an email address, as the scammers may misspell an official reputed company email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at reputed company, please only deal directly with reputed company through its official reputed company Career website https://reputed company.wd1.myworkdayjobs.com/en-US/External. reputed company will not be held liable or responsible for any claims, losses, damages or expenses resulting from job reputed company scams. If you suspect a position is fraudulent, please contact reputed company’s call center at: 800-363-5670. If you reputed company you are the victim of fraud resulting from a job reputed company scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities. reputed company America Pharmaceutical Inc., reputed company Pharmaceutical Development & Commercialization, Inc., and reputed company Precision Health, Inc. (“reputed company”) does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company/resumes submitted by search firms to any reputed company employee directly or through reputed company’s application portal without a valid written search agreement in reputed company for the position will be considered reputed company’s sole property. No fee will be reputed company if a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Apply To This Job